Kedrion Launches FDA-Approved Gammaked in the U.S. Market
- By BSTQ Staff
The U.S. Food and Drug Administration has approved Kedrion Biopharma’s Gammaked, a 10 percent liquid, ready-to-use sterile solution of human immune globulin, for the U.S. market. Gammaked is approved for intravenous administration for primary immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy, and for subcutaneous administration to treat primary immunodeficiency. It is supplied in 1-, 2.5-, 5-, 10- and 20-gram single-use bottles. Kedrion has entered into an agreement with Grifols SA to manufacture Gammaked for the next seven years. And, as part of its ongoing expansion in the U.S., Kedrion began distribution of Gammaked on August 2 through designated channel partners.